Legislation

Therapeutic Goods (Poisons Standard, October 2026) Instrument 2026

Therapeutic Goods Administration. Legislative instrument, Australia-wide.

Version
Poisons Standard October 2026, made 28 September 2026
Last read
5 October 2026

F2026L01327. The Poisons Standard is remade several times a year, so the instrument in force changes name with it. It is the instrument that decides which schedule a substance sits in, which Queensland's own legislation then applies. Its Schedule 4 covers injectable tissue augmentation materials, and its Appendix A carves those materials out of the exemption that would otherwise cover a Class III medical device, so a filler can be both a device on the register of therapeutic goods and a scheduled medicine.

What changed

  • 1 October 2026Poisons Standard October 2026 (F2026L01327)Made on 28 September 2026 and commencing on 1 October 2026; section 4(1) repeals the June 2026 instrument. The entries this register quotes, including hyaluronic acid, calcium hydroxylapatite, polylactic acid and polycaprolactone, are word for word unchanged. Compared with the June 2026 text line by line on 5 October 2026, the changes are these.
    • Schedule 4 adds bempedoic acid, efanesoctocog alfa, enflicoxib, eplontersen, gadoquatrane, gepotidacin, lonapegsomatropin, olutasidenib, somatrogon, tapinarof and teplizumab.
    • Schedule 4 renames orebrutinib to orelabrutinib.
    • The Schedule 4 entries for enzalutamide, macitentan, pomalidomide and somapacitan now carry the # mark, which the instrument says shows a substance listed in Appendix D. Appendix D adds lonapegsomatropin, somapacitan and somatrogon.
    • Schedule 5 adds green tea extract (Camellia sinensis) for oral use, with two exceptions, and spidoxamat.
    • Schedule 6 adds BPA glycidyl diacrylate and BPA glycidyl dimethacrylate in preparations for cosmetic use, and dimethyl disulfide as a soil fumigant.
    • Schedule 9 adds 6-methylnicotine.
    • Schedule 10 lowers the lead limit for anti-fouling paints from 0.1% to 0.06%.
    • Appendix B adds Bacillus paralicheniformis, and Appendices E, F and L add the first aid, warning and dispensing label statements for the new entries.
    • References to Therapeutic Goods Orders 91 and 92 now name the labelling orders TGO 115 and TGO 116.
  • 1 June 2026Poisons Standard June 2026 (F2026L00633)Made on 27 May 2026 and commencing on 1 June 2026. The Federal Register records it as repealed from 1 October 2026.
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